Kornimate/medical-research-clean huggingface dataset:
study of mitomycin-c application in laryngotracheal stenosis

Conditions: Laryngeal Stenosis; Subglottic Stenosis; Tracheal Stenosis

Summary: this is a randomized, prospective, double-blind, placebo-controlled clinical trial of the use of mitomycin-c topical application as an adjunctive treatment in the endoscopic surgical treatment of patients with laryngotracheal stenosis. we hypothesize that the use of mitomycin-c improves patient outcome in the endoscopic surgical treatment of laryngotracheal stenosis.

obstruction of the upper airway caused by laryngotracheal stenosis (lts) often results in severe morbidity and even mortality. treatment of lts continues to present a challenge and a wide array of surgical techniques have been employed. despite multiple endoscopic and/or open reconstructive procedures, patients often experience restenosis as a result of the abnormal wound-healing process that initially instigated the airway obstruction. the high rate of stenosis relapse has therefore motivated researchers to find new methods to modulate and control the wound-healing process of the airway. although other adjuvant treatments such as steroids and antibiotics have been investigated in lts, much attention in recent years has turned to the use of topical mitomycin-c (mmc). as a topical application, mmc has been shown to inhibit fibroblast proliferation in wound-healing processes. the use of mmc in the treatment of airway stenosis was first reported in 1998 and is now routinely used in the endoscopic management of lts. however, despite numerous animal and human studies, the benefit of mmc in lts patients remains questionable. while previously published retrospective data suggest that the addition of mmc improves outcome, there have been no prospective studies to directly address the efficacy of mmc in endoscopic lts surgery. this study will be the first randomized, prospective, double-blind, placebo controlled clinical trial designed to investigate the efficacy of mmc as an adjunctive therapy to endoscopic surgical treatment in patients with lts. in addition, the study will investigate the relationship between patient symptoms and objective pulmonary function measurements. ultimately, the results of this study may influence the treatment and evaluation of patients with laryngotracheal stenosis.

Eligibility criteria:
inclusion criteria: * patients with laryngotracheal stenosis, including subglottic stenosis or tracheal stenosis * patients with disease amenable to treatment with endoscopic co2 laser radial incisions and balloon dilation * age greater than or equal to 18 years exclusion criteria: * age less than 18 years * pregnancy * patients with glottic and supraglottic stenosis * patients with disease not amenable to treatment with endoscopic co2 laser radial incisions and balloon dilation * patients with cartilaginous subglottic or tracheal stenosis

Keywords: mitomycin-c laryngotracheal stenosis subglottic stenosis tracheal stenosis endoscopic airway surgery
measurement of the cerebral saturation for assessment of safety of epidural anaesthesia during abdominal surgery

Conditions: Surgical Complications From General Anesthesia; Cerebral Ischemia; Anesthesia; Reaction

Summary: subsequent and non-randomised patients, adult patients qualified for major abdominal surgeries were enrolled


Eligibility criteria:
inclusion criteria: * scheduled for major abdominal surgery for at least 2 h * under general anesthesia * american society of anesthesiologists（asa）physical status : ii \~ iii * age \> 18 exclusion criteria: * refuse of patients * patient with results of test: "the mini mental state examination"" less then 24 before operation * neurosurgery history of patients

Keywords: cerebral saturation epidural anaesthesia near infrared spectroscopy (nirs) regional cerebral oxygen saturation
happy hands - an e-self-management intervention for people with hand osteoarthritis

Conditions: Hand Osteoarthritis

Summary: the main aim of this project is to assess the effect, cost-effectiveness and user experiences with using an e-self-management intervention in addition to treatment as usual compared to treatment as usual alone in patients with hand osteoarthritis. the study is an rct comprising approx 400 participants with hand osteoarthritis recruited from primary and secondary healthcare in all four health regions in norway.

hand osteoarthritis (oa) is a highly prevalent rheumatic joint disease, and the number of people living with debilitating hand oa will continue to rise in the coming decades due to increased life expectancy. research shows that patients with hand oa have poor access to recommended treatment, and in norway, they are increasingly referred to surgical consultation before having received recommended first-line treatment. thus, there is a need to develop easily viable models of care for patients with hand oa that make recommended treatment available across different healthcare levels. our hypotheses are that an e-self-management intervention for people with hand oa will improve pain and function and be more cost-effective compared to treatment as usual, and that this app can easily be implemented in both specialist and primary healthcare. the hypotheses will be tested and explored in a randomized controlled trial, with a qualitative study nested within this trial. the main research questions are: 1. to evaluate whether a 12-week e-self-management intervention is more effective in improving pain and function (according to the omeract-oarsi responder criteria26) compared to usual care in patients with hand oa (randomized controlled trial). 2. to determine the cost-effectiveness of the e-self-management intervention compared to usual care after 6 months (randomized controlled trial). 3. to explore patients' experience of barriers and facilitators for adopted and continued use of a e-self-management intervention for treatment of hand oa (qualitative interviews). secondary research questions will also be assessed. approx 400 patients will be recruited in this multicenter randomized controlled trial where patients with hand oa are allocated to either usual care or a 12-week e-self-management intervention delivered through a smartphone app (the happy hands app). outcome measures are collected at baseline, 3 months (=end of intervention) and 6 months

Eligibility criteria:
inclusion criteria: * people diagnosed with hand osteoarthritis * possessing a smartphone exclusion criteria: * cognitive deficits * are scheduled for hand surgery within the next 3 months * do not talk or understand norwegian, * have uncontrolled serious comorbidities
validation durability adenosine effect in verification pulmonary vein isolation

Conditions: Atrial Fibrillation

Summary: adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins during atrial fibrillation ablation, however, the methodology has not been validated either in terms of the reproducibility of the adenosine response or the effect on clinical outcomes, namely whether using pulmonary vein reconnection to guide additional ablation lowers rate recurrent atrial fibrillation post ablation. study will test the hypothesis that the response to adenosine used in this manner is reproducible over time.

patients undergoing pulmonary vein isolation as part of atrial fibrillation ablation will be randomized to treatment and control groups. treatment group subjects will received 12 mg iv adenosine to evaluate pulmonary vein reconnection after initial electrical isolation is documented. if electrical reconnection is not observed at 5 minutes, a second dose of adenosine will be administered, monitoring again for electrical reconnection. control patients will be observed for 10 minutes post initial electrical isolation of the pulmonary vein for spontaneous electrical reconnection. if reconnection is observed, veins will be re-isolated per standard clinical practice. this procedure will be repeated for each of a patient's pulmonary veins. patients will be followed up at clinical visits to examine for adverse effects of procedure and/or adenosine administration as well as atrial fibrillation recurrence.

Eligibility criteria:
inclusion criteria: * patients undergoing atrial fibrillation ablation, pulmonary vein isolation by catheter for standard clinical indications exclusion criteria: * allergy or contraindication to adenosine, * inability to give informed consent, * currently taking dipyridamole, * verapamil or theophylline and * breast-feeding mothers.

Keywords: atrial fibrillation ablation pulmonary veins adenosine
study of the safety, pharmacodynamics, efficacy, and pk of timp-glia in subjects with celiac disease

Conditions: Celiac Disease

Summary: subjects enrolled in this study will be evaluated for immune responses and histological changes in the small bowel following 2 doses of timp-glia or placebo and a 14-day oral gluten challenge.

this study is a randomized, double-blind, placebo-controlled clinical trial to assess the safety, pharmacodynamics, efficacy, and pk, of timp-glia in subjects with well-controlled celiac disease (cd) following an oral gluten challenge. subjects aged 18 to 70 years inclusive, with documented history of biopsy-proven confirmed cd, and on a gluten-free diet (gfd) for a minimum of 6 months, will be screened. subjects who meet all inclusion and no exclusion criteria, and provide written informed consent, will be randomized within 45 days after screening to receive 2 intravenous (iv) infusions of timp-glia, 8 mg/kg up to a maximum of 650 mg or placebo (normal saline) in a 1:1 ratio. treatment with drug or placebo will be followed by 14 days gluten challenge.

Eligibility criteria:
key inclusion criteria: 1. male or nonpregnant female, ages 18 to 70 years inclusive, at screening visit. 2. biopsy-confirmed cd (intestinal histology showing villous atrophy). 3. positive for human leukocyte antigen (hla)-dq2 or hla-dq2/dq8 - results will be obtained at screening if unknown or results are not available. 4. self-reported to be on a gfd for at least 6 months prior to screening and agree to continue gfd throughout study, with the exception of the oral gluten challenge. normal or negative celiac serology, at screening, defined as: 1. measurable total serum immunoglobulin a (iga) and 2. negative or weak positive tissue transglutaminase (ttg) iga titer or 3. if iga deficient, defined by a serum iga level of \< 3 mg/dl, negative or weak positive dgp- igg titer. 6. vh:cd ≥ 1.5 on screening biopsy. key exclusion criteria: 1. positive for only hla-dq8. 2. history of clinically confirmed immunoglobulin e (ige)-mediated reaction and/or anaphylaxis to wheat (i.e., "wheat allergy"), barley or rye. 3. uncontrolled cd and/or active signs/symptoms of cd, in the opinion of the investigator. 4. untreated or active gastrointestinal disease such as peptic ulcer disease, esophagitis (los angeles classification ≥ grade c), irritable bowel syndrome, inflammatory bowel disease, or microscopic colitis. 5. immunocompromised individuals, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternative days for 2 weeks or more within 6 months prior dose 1, any dose of corticosteroids within 30 days of day 1, or high dose inhaled corticosteroids \[\> 960 µg/day of beclomethasone dipropionate or equivalent\]) or other immunosuppressive agents. 6. presence or history of celiac-associated thyroid disease or type 1 diabetes, regardless of current treatment.
a multicenter registry study of aneurysmal sah

Conditions: Subarachnoid Hemorrhage, Aneurysmal; Time Delay

Summary: firstly, this study aims at clarifying the current situation of emergency treatment of aneurysmal subarachnoid hemorrhage (sah) in china, and analyzing the influencing factors contributing to transport delay, so as to improve the efficiency of emergency treatment; secondly, comparison and analysis of different surgical treatment of aneurysmal sah would be undertook, so as to improve the diagnosis and treatment of aneurysmal sah.


Eligibility criteria:
inclusion criteria: * patients presented with subarachnoid hemorrhage on ct or lumbar puncture. * the intracranial hemorrhage was caused by rupture of aneurysm and was confirmed on cta、mra or dsa. * patients willing to participate in this clinical trial and attach to regular follow up. exclusion criteria: * intracranial aneurysm correlating to avm. * dissection, false, traumatic and infectious aneurysms. * the rupture of the aneurysm can not be confirmed on cta、mra or dsa.
using combine walking and elastic band to decrease fatigue

Conditions: Cancer Related Fatigue

Summary: this study is expected to propose an industry-university cooperation research case for the next two years. when cancer patients use epro to record subjective fatigue, and smart watches with 4g communication record objective fatigue, they will be given according to the patient's current degree of mild, moderate and severe fatigue. suffer from 'exercise or activity' advice and lead the implementation of appropriate exercise advice. this study is expected to design aerobic + anaerobic exercise suitable for mild or moderate patients, and use the sensor of the smart watch to monitor the effect of exercise and fatigue. to sum up, the first-year plan is expected to use the established epro electronic records, combined with the line communication system, to integrate into a "cancer-related fatigue electronic registration and care system"; the second-year plan will integrate objective fatigue classifiers, establish the exercise care option in the fatigue care system, and use the smart watch to establish a technology record function of the exercise process to help track the fatigue level of cancer patients.


Eligibility criteria:
inclusion criteria: 1. age 20 years old; 2. diagnosis of cancer; 3. can continuous wearing bracelet for 14 days or more exclusion criteria: 1. unclear and unable to answer the questionnaire； 2. not able to walk； 3. platelet \<50,000/mm3； 4. anc 500/cumm
internal limiting membrane and macular hole

Conditions: C11.768.740

Summary: observational study of internal limiting membrane peeled in macular hole surgery and studied by transmission electronic microscopy (tem) and optical coherence tomography (oct) findings in closed holes.

a non-randomized prospective study of eyes with mh willing to have surgery at the department of ophthalmology of santa maria hospital, lisbon. surgeries are performed under local or general anesthesia, pars plana vitrectomy with internal limiting membrane peeling, fluid gas exchange and face down position. two samples of discarded ilm peeled in macular hole surgery is studied in laboratory. laboratory analysis two samples of ilm per patient are harvested, one will be immediately fixed and submitted to optic microscopy (om) and transmission electron microscopy (tem) analysis, and another sample will be incubated in enriched medium 199 (gibco) for 20 minutes at room temperature, after which it will also be fixed and submitted to om and tem analysis. both samples from same patient will follow the protocol available at dx.doi.org/10.17504/protocols.io.qjiduke. image acquisition six electron-micrographs will be acquired for each fragment, using a hitachi h-7000 electron microscope equipped with a megaview iii digital camera. fields of interest will be randomly selected, and acquisition of 15,000x magnification images. histology and immunohistochemistry ilm samples will be stained with anti-gfap antibody (anti-glial fibrillary acidic protein), to detect this protein in glial cells. results: only successful macular hole closure will be considered, bcva will be compared before and after surgery and related to oct findings. ilm findings in tem analysis will be compared with and without enriched medium.

Eligibility criteria:
inclusion criteria: * all macular holes were staged based on recent oct based classification and only full thickness macular hole, grade 2 to 4 imh are considered for study. exclusion criteria: * excluding criteria are maculopathy other than imh, surgeries of recurrence of imh, other retinal diseases, or an axial length greater than 26.0 mm. mean follow-up will be at least 12 months after surgery.
study of wpv01 compared with placebo in patients with mild/moderate covid-19 infection

Conditions: COVID-19 Infection

Summary: a randomized, double-blind, placebo-controlled phase ii clinical study to evaluate the efficacy and safety of wpv01 in patients with mild/moderate covid-19 infection


Eligibility criteria:
inclusion criteria: 1. participants ≥18 years of age when signing icf; 2. initial onset at least 1 of 11 covid-19 symptoms within 48 hours before randomization; 3. within three days before randomization, the rt-pcr test of specimens such as nasal and pharyngeal swabs must be positive for sars-cov-2 or the rapid antigen test must be positive, and also the patiets should meet the diagnostic criteria for mild or moderate cases as defined in the diagnosis and treatment protocol for covid-19 (trial version 10) issued by the national health commission of china; 4. fertile participants must agree to take effective contraceptive measures; 5. participants who understand and agree to comply with planned study procedures，voluntarily participate in this clinical trial and sign an informed consent form. exclusion criteria: 1. known allergy to any ingredient in the study treatment drug; 2. patients who meet the diagnostic criteria for severe or critical cases of covid-19 as defined in the diagnosis and treatment protocol for novel coronavirus pneumonia (trial version 10) issued by the national health commission of china at the time of randomization; 3. obvious abnormal liver function (alt or ast ≥ 3uln, or total bilirubin ≥1.5uln); 4. on dialysis or combined with moderate to severe kidney injury; 5. patients with compromised immune system; 6. patients with acute exacerbation of chronic respiratory disease at screening, including bronchial asthma, chronic obstructive pulmonary disease; 7. patients with suspected or confirmed concurrent active systemic infection other than covid-19 at screening; 8. any comorbidity requiring surgery within 14 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator; 9. has received or is expected to receive covid-19 monoclonal antibody or convalescent covid-19 plasma during study treatment; 10. has received treatment with antivirals against sars-cov-2 within 14 days prior to randomization; 11. has received any novel coronavirus infection vaccine within 1 week prior to randomization; 12. current or expected use of strong cyp3a4 inducers, inhibitors or medications that are highly dependent on cyp3a4 for clearance; 13. difficulty swallowing or a history of gastrointestinal disorders that severely interfere with drug absorption; 14. bmi≥30 kg/m2; 15. pregnant, lactating women or those with a positive pregnancy test; 16. previous administration with any investigational drug within 3 months before the study drug administration; 17. patients who are judged by the investigator to be unsuitable to participate in this study.
continuation protocol for zen003694 in patients experiencing clinical benefit while enrolled in a zen003694 protocol

Conditions: mCRPC

Summary: continuation protocol for zen003694 in patients experiencing clinical benefit while enrolled in a zen003694 protocol

this is an open label, non-randomized, single-arm continuation protocol study using zen003694. patients who have completed participation in their original ("parent") zen003694 protocol and have clinical benefit as determined by the investigator may continue to receive treatment with zen003694 in the continuation protocol. the patient must have been enrolled in a zenith epigenetics sponsored zen003694 therapeutic study to be eligible for participation in this continuation protocol.

Eligibility criteria:
inclusion criteria: 1. protocol-defined completion in a parent zen003694 trial 2. patient has clinical benefit as determined by the investigator at the time of entry to the continuation protocol 3. ecog performance status of 0 or 1 4. acceptable zen003694 tolerability, in the judgment of the investigator 5. initiation of dosing in this continuation trial to occur within two weeks (14 days) of completing dosing in the parent trial, unless more time is approved by the sponsor in writing exclusion criteria: 1. concurrent participation in another clinical investigational treatment trial 2. require addition of or change to a new concomitant therapy to adequately treat the malignancy under study 3. discontinued zen003694 or withdrew consent to participate in original zenith epigenetics-sponsored zen003694 study 4. any other reason that in the opinion of the investigator would prevent the patient from completing participation or following the study schedule

Keywords: zenith prostate cancer
efficiency study of clarithromycin and bismuth-containing quadruple therapy to treat h.pylori

Conditions: Functional Dyspepsia; Peptic Ulcer; Helicobacter Pylori

Summary: the purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for h.pylori treatment.

the success rate of currently recommended triple therapy with a proton pump inhibitor (ppi) plus amoxicillin and clarithromycin has fallen into the unacceptable range. the purpose of this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing quadruple therapy for h.pylori treatment, while ten day triple therapy is used as control.

Eligibility criteria:
inclusion criteria: * patients who presented with upper gastrointestinal symptoms and endoscopically proven h.pylori-positive functional dyspepsia and scarred peptic ulcers exclusion criteria: * patients less than 18 years old, with history of h. pylori infection treatment, with previous gastric surgery, pregnancy, lactation, major systemic diseases, administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks, or allergy to any one of the given medication in the regimens.
rct with adjuvant mistletoe treatment in gastric cancer patients

Conditions: Gastric Cancer

Summary: evaluation of safety and efficacy of a standardized mistletoe extract (abnobaviscum® quercus, avq) in patients with gastric cancer receiving oral chemotherapy.


Eligibility criteria:
inclusion criteria: * postoperative uicc stage ib/ii gastric carcinoma * indication for oral chemotherapy with doxifluridine * ecog performance status 0 or 1 * normal liver and kidney function exclusion criteria: * inability to answer the qol scales * concomitant therapy with steroids or biological response modifiers * individual hypersensitivity to mistletoe preparations * pregnancy or lactating * participation in another clinical trial

Keywords: quality of life qol eortc qlq-c30 eortc qlq-sto22 5-fu viscum album